Home / Recalls / Medical Devices
Elekta, Inc. recalls All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product
Recalled March 12, 2014 · FDA recall Z-1065-2014 · Elekta
Hazard
Customers are resetting the default values outside recommended factory settings. · FDA Class II
Units
472 units
Sold at
USA Nationwide Distribution in the states of: AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC and including Puerto Rico.
Description
Customers are resetting the default values outside recommended factory settings.
Product
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes
Manufacturer(s)
Elekta, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →